BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO NEEDLE

    MDR report key: 8784891 · Received July 12, 2019

    Report

    Report Number
    3003902955-2019-00031
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 8, 2019
    Report Date
    July 12, 2019
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K121607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THEREFORE THE INVESTIGATION WAS BASED ON THE ACTUAL SAMPLE, PHOTOS RECEIVED AND RETENTION SAMPLES. BASED ON THE RESULTS OF OUR INVESTIGATION AND SERIES OF SIMULATIONS CONDUCTED BY PRODUCTION AND MOI TEAM, THE INSUFFICIENT AMOUNT OF GLUE ORIGINATED FROM OUR PRODUCTION AT BONDING STATION DURING SETTING-UP AND ADJUSTMENT OF DOCTOR BLADE TO SET UP GLUE AMOUNT AFTER RUBBER HOLD REPLACEMENT. OUR RECORD SHOWED THAT THE SUPPLIED NEEDLE ASSEMBLY ON UB # (B)(4) WAS AFFECTED BY RUBBER HOLD REPLACEMENT (START OF THE SHIFT). MOST LIKELY, DURING RUBBER HOLD REPLACEMENT, THE TECHNICIAN TURNED OFF THE GLUE SUPPLY AND ADJUST DOCTOR BLADE TO SET UP THE GLUE AMOUNT. PROBABLY, SINCE THE TECHNICIAN IS STILL ADJUSTING THE GLUE AMOUNT HE ACCIDENTALLY SET THE VERTICAL AND HORIZONTAL DISC DEPTH BEYOND THE VALIDATED PARAMETER THEREBY CREATING THE COMPLAINT DEFECT. THE JIGS AFFECTED BY THE ADJUSTMENT WAS NOT TAKEN OUT BY THE ON LINE INSPECTOR THEREFORE THE JIG PROCEEDED AT DRYING TUNNEL UNTIL GOOD PRODUCT EJECTION. THE PARAMETER WAS SET AGAIN ON THE ORIGINAL SETTING PRIOR PRODUCTION RUNNING SINCE IT IS BEING RECORDED ON THE CHECK SHEETS. SINCE THE CAMERA DETECTION INSPECTS ONE SIDE OF THE PRODUCT, THE CANNULA SIDE WITH GLUE WAS SCANNED BY THE INSPECTION SYSTEM HENCE THE ACTUAL SAMPLE PASSED AND JUDGED AS GOOD. THIS LIMITATION OF INSPECTION SYSTEM CAN BE CONTROLLED THRU PROCESS MONITORING AND ACTIVITIES SUCH AS: SKILL OF OPERATOR ADJUSTMENT ON BONDING STATION. ON-LINE INSPECTION 1 AND 2. ALSO, THE DEFECT WAS NOT NOTICE DURING PRODUCT CONFIRMATION SINCE THE FOCUS OF INSPECTION IS FM ON CANNULA NOT ON THE GLUE AMOUNT. WE HAVE CONFIRMED ON OUR PRODUCTION PROCESS THAT THIS DEFECT IS UNLIKELY TO HAPPEN UNDER NORMAL PRODUCTION CONDITION. OCCURRENCE OF THE DEFECT IS CONSIDERED ISOLATED BASED FROM OUR SERIES OF SIMULATIONS. THE INFORMATION WAS ALREADY CASCADED TO ALL OUR ASSOCIATES LAST JUNE 21, 2019 AND AS INITIAL ACTION, PQD-NN010 WAS REVISED ((B)(6) 2019) TO INCLUDE THE RECORDING OF CONFIRMATION RESULT OF GLUE AMOUNT AFTER REPLACEMENT OF RUBBER HOLD ON NN-011 NN MACHINE DAILY OPERATION REPORT (DOR). FURTHER ENHANCEMENT ON THE WORK INSTRUCTION ON HOW TO HANDLE THE AFFECTED PRODUCTS (JIG AND BAG) AND ENSURING THE PRESENCE OF THE ON-LINE INSPECTOR SHALL BE INCLUDE ON JULY 06, 2019.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING BLOOD SAMPLING WITH A SYRINGE, AIR INCLUSION WAS OBSERVED. THE BLOOD SAMPLING WAS SUCCESSFULLY DONE AFTERWARDS. HOWEVER, THE CANNULA DETACHED OFF FROM THE HUB DURING THE WITHDRAWAL AND REMAINED ON THE PATIENT'S SKIN. THERE WAS NO HEALTH HAZARD OR NO BLOOD CONTAMINATION WAS CONFIRMED FROM REMAINED BLOOD ON DETACHED CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578972 TERUMO NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A 190207F

    Patients

    Seq Age Sex Outcome Treatment
    1